NA M-35SD-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384015574), received between Jan 24, 2023 and Jan 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (2 reports).

39 other recalls cover devices cleared under the same FDA submission (K113476); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2023Environmental Particulates; Excessive Heating; Environmental Particulates; Excessive Heating

  THIS IS EVENT 2 OF 2 OF THE SAME EVENT IT WAS REPORTED FROM CANADA THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO CUTTER DEVICES OVERHEATED WHEN APPLIED TO THE BONE WHILE IN USE WITH A MOTOR DEVICE AND AN ATTACHMENT DEVICE. ACCORDING TO THE REPORTER, THE NURSE FELT THAT THE CUTTER DEVICE WAS HOTTER THAN USUAL. NO INJURY WAS REPORTED AND HER GLOVES WERE NOT DAMAGED. THE MOTOR DEVICE AND ATTACHMENT DEVICES WORKED FINE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. SPARE DEVICES WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232737 ↗
• MalfunctionJan 24, 2023Environmental Particulates; Excessive Heating; Environmental Particulates; Excessive Heating

  THIS IS EVENT 1 OF 2 OF THE SAME EVENT. IT WAS REPORTED FROM CANADA THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO CUTTER DEVICES OVERHEATED WHEN APPLIED TO THE BONE WHILE IN USE WITH A MOTOR DEVICE AND AN ATTACHMENT DEVICE. ACCORDING TO THE REPORTER, THE NURSE FELT THAT THE CUTTER DEVICE WAS HOTTER THAN USUAL. NO INJURY WAS REPORTED AND HER GLOVES WERE NOT DAMAGED. THE MOTOR DEVICE AND ATTACHMENT DEVICES WORKED FINE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. SPARE DEVICES WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232734 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113476. One submission often covers many models, so check the product and lot details in each record.

• Z-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
• Z-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
• Z-2838-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2840-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2296-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
• Z-2306-2015 · Apr 13, 2015 · Terminated
  ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
• Z-2304-2015 · Apr 13, 2015 · Terminated
  ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.
• Z-2289-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
• Z-2287-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
• Z-2288-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
• Z-2285-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
• Z-2286-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
• Z-2295-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
• Z-2305-2015 · Apr 13, 2015 · Terminated
  ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.

…and 24 more.